510(k) submission software for faster FDA clearance.
REGARA compresses the Premarket Notification 510(k) — from predicate search to substantial-equivalence drafting — into one auditable workspace built for medical device regulatory teams.
A 510(k) is a premarket submission made to the FDA to demonstrate that a medical device is at least as safe and effective as a legally marketed predicate device — the standard known as substantial equivalence. It is the most common route to the U.S. market, clearing the large majority of Class II devices.
Since October 2023, 510(k)s must be filed through the FDA’s electronic eSTAR template, and submissions now pass a technical screening (formerly Refuse to Accept) before substantive review. Getting the structure, predicate rationale, and performance evidence right the first time is what separates a first-cycle clearance from months of deficiency letters.
REGARA is built for exactly that: it drafts each eSTAR section against live FDA guidance, anchors every claim to its source, and surfaces the predicate evidence your reviewer will expect to see.
- 01Substantial-equivalence drafting
Draft the indications, device description, and SE discussion directly against the current 510(k) and eSTAR guidance — with citations attached to every assertion.
- 02Predicate intelligence
Find and rank substantially equivalent predicates by indication, technology, and SE proximity, then auto-build the side-by-side comparison table.
- 03Performance-testing dossier
Organize bench, biocompatibility, and software documentation against the recognized consensus standards the FDA expects for your device type.
- 04Deficiency prevention
A reviewer simulator flags the gaps most likely to trigger an Additional Information request before you submit — not after.
Why first-cycle clearance is getting harder.
The administrative gate.
A large share of 510(k)s stall at technical screening on documentation gaps that have nothing to do with the science. REGARA structures the eSTAR package so it passes the first time.
Predicate drift.
Roughly a fifth of clearances lean on predicates over a decade old. REGARA surfaces the strongest, most current predicates and documents the rationale.
Traceability.
Reviewers reward submissions that show their work. Every REGARA output cites the guidance, standard, or study it rests on — click to verify.
- QWhat is 510(k) submission software?
510(k) submission software helps medical device teams prepare a Premarket Notification for the FDA — drafting the eSTAR sections, identifying substantially equivalent predicate devices, assembling performance testing, and keeping every claim traceable to its source. REGARA does this in one auditable workspace.
- QHow long does 510(k) clearance take?
The FDA targets 90 review days for a Traditional 510(k), but total calendar time is often longer once Additional Information requests are included. Passing technical screening cleanly and pre-empting reviewer questions is the biggest lever on total time — which is what REGARA is designed to do.
- QWhat is substantial equivalence?
Substantial equivalence means a new device has the same intended use and the same technological characteristics as a legally marketed predicate — or different characteristics that do not raise new questions of safety and effectiveness, supported by performance data. It is the core standard a 510(k) must meet.
- QIs eSTAR required for a 510(k)?
Yes. Since October 1, 2023, the FDA requires 510(k)s to be submitted using the electronic eSTAR template. REGARA drafts directly against the eSTAR structure so your package is submission-ready without reformatting.
Explore related pathways and research.
Find substantially equivalent predicates by indication, technology, and SE proximity.
PathwayBuild a special-controls case for a novel device with no valid predicate.
White paperHow RTA gatekeeping and predicate drift stall device innovation and global access.
Clear your next 510(k) faster.
Bring a real device. In a 30-minute working session we’ll draft an eSTAR section and surface predicates against your indication.